dabigatran guidelines and reversal ppt
DESCRIPTION
Dabigatran 2013 PPTTRANSCRIPT
DabigatranDr Ihab Suliman
2013
The New Oral Anticoagulants:Similar Yet Different
Thrombin Inhibitors:1. Dabigatran: pro-drug, renal clearance - twice daily
FXa Inhibitors:1. Rivaroxaban: renal clearance - once daily2. Apixaban: hepatic clearance - twice daily3. Edoxaban: hepatic clearance - once daily
Circulation 2010;121:1523-1532
Dabigatran: FDA Status
Pradaxa trade name
For the prevention of DVT/PE after orthopedic surgery:Pradaxa approved in EU and Canada
For the prevention of stroke in patients with non-valvular atrial fibrillation (SPAF):Pradaxa 150 mg BID FDA approved (Oct. 2010)
Pradaxa approved in EU, Canada and Japan
Dabigatran: FDA Approved Dosing
150 mg BID for SPAF 150 mg for CrCl >30 mL / min
75 mg for CrCl 15-30 mL / min
Stroke from Atrial Fibrillation
AF is the most preventable cause of stroke:12-16 million will be on warfarin treatment by
2050 in the USClinical trials have shown stroke can be
reduced:Placebo vs ASA = 19% ASA vs warfarin = 30% Placebo vs warfarin = 62% Dabigatran vs warfarin = 34%
Dabigatran: Not Without Issues1. No anticoagulant effect if missed dose
• 2% discontinuation rate due to GI distress
• Cost of drug ($240/mo vs $4/mo for warfarin)
2. No test to assess anticoagulation
3. Difficult to modulate dose
4. Bleeding in the elderly and renal impaired patients (5 dabigatran related deaths in Japan)
5. ‘Real world’ untested populations
6. Drug interactions
7. Limited data on bridging between anticoagulants
8. No specific antidote
9. 0.2% increase in myocardial infarction
10. Off-label use
Dabigatran: Laboratory Testing
Monitoring vs anticoagulant assessment PT and aPTT
Differing reagent sensitivities
Not a linear association between assay values and drug level
Not validated for association to bleeding
aPTT may be applicable for qualitative assessment
INR: not sensitive; not validated
TT: Super-sensitive; can identify if any drug onboard
Ecarin clotting time: results can vary depending on plasma factors; research use only (RUO)
PiCT: RUO
Chromogenic anti-FIIa
Hemoclot: quantitative using dabigatran calibrators; FDA approved yet?